The study, funded by the National Institute for Health and Care Research (NIHR), showed that active monitoring of low- and many intermediate-risk prostate cancers was safe and that death rates were essentially the same whether the men were assigned to surgery, or radiation, or were followed with what is now known as active surveillance.
Professor Freddie Hamdy, FRCS, Head of the Nuffield Department of Surgical Sciences at the University of Oxford and lead investigator of the ProtecT trial, said: “I want to say how touched I am for the ProtecT team by this generous award and recognition of our work by ASPI, and what a wonderful surprise it is. It feels so very special to be recognised by the very people we have been trying to help.
“We started ProtecT over 25 years ago, because we wanted to help patients with PSA-detected prostate cancer to decide what treatment to choose, which can be daunting, by providing high-quality evidence, and importantly measuring and analyzing patient-reported outcomes alongside the clinical outcomes of our trial. We did not know what to expect. But with our findings, we do believe that it now allows men to consider all options, and to have confidence in active surveillance when appropriate.”
Jenny Donovan, Professor of Social Medicine at the Bristol Medical School: Population Health Sciences (PHS) and co-lead investigator, added: “I am also absolutely thrilled and honored that we have been nominated for this ASPI Special Award. We set out all those years ago, involving patients at every stage of the study, to provide high-quality information about the trade-offs that are needed when making the decision about which treatment pathway to follow.”
The ProtecT team recently published the 15-year clinical and 12-year patient-reported outcomes of the study in the New England Journal of Medicine. Researchers reported on 1,643 patients. After an average 15 years of follow-up, prostate cancer–specific mortality was low (around 3 per cent) regardless of the treatment assigned.
The study also reported that there was an increased risk of cancer spread with active monitoring, and side-effects following surgery and radiotherapy that included urinary leakage and impaired sex life over at least 12 years.
Mark Lichty, co-founder and chairman of ASPI, said: “ProtecT has been a game-changer for tens of thousands of men who decide to go on active surveillance with confidence about safety with appropriate surveillance.”
He added: “ProtecT proved that active surveillance, close monitoring of lower-grade prostate cancers, can spare men from unnecessary treatment and protect their quality of life.”
Paul Schellhammer, MD, a member of the ASPI awards committee, a urologist, prostate cancer patient, and past president of the American Urological Association, explained: “The ProtecT Trial accomplished a scientific feat, which overcame two of the greatest obstacles in the advancement of knowledge of prostate cancer therapy--first, a randomized control trial involving three different therapies and second, the extraordinary15-year follow with survival and quality of life data. The full spectrum of medical care and medical inquiry personnel, nurses, counselors, physicians, and statistical and social scientists are to be congratulated and appropriately honored.”
The 2024 ASPI Special Award was presented to Professors Freddie Hamdy and Jenny Donovan via an online ceremony last month. The project team received an original painting by artist Kathy Lockwood, symbolizing how patients and physicians can work together to “First, Do No Harm” (Hippocrates) and preserve patients’ quality of life.